Brenda Bagby
About Brenda Bagby
Brenda Bagby serves as the International RA Senior Specialist at AtriCure, Inc., where she has worked for 17 years. She specializes in regulatory affairs, preparing EU Technical Documentation and managing projects to secure marketing approvals.
Work at AtriCure
Brenda Bagby has been employed at AtriCure, Inc. since 2007, initially serving as a Clinical & Regulatory Affairs Coordinator for 17 years. In 2017, she transitioned to the role of International RA Senior Specialist, where she has worked for 7 years. Her responsibilities include preparing EU Technical Documentation to secure and maintain marketing approvals, as well as updating the Technical File annually. She acts as a regulatory liaison with global Regulatory Authorities to facilitate timely reviews of submissions and pre-submission activities.
Education and Expertise
Brenda Bagby studied at Oakland University, where she gained foundational knowledge relevant to her career in regulatory affairs. Her expertise encompasses global regulatory strategies for both new product development and sustaining projects. She independently manages multiple projects within the regulatory affairs domain, demonstrating her capability in navigating complex regulatory environments.
Regulatory Affairs Responsibilities
In her role, Brenda Bagby interfaces directly with Notified Bodies and Regulatory Authorities during review cycles and pre-planning sessions. She provides guidance on regulatory strategies and supports operations activities, including updates to Standard Operating Procedures and Work Instructions. Additionally, she is involved in Product Lifecycle Management database activities, ensuring compliance and efficiency in regulatory processes.
Project Management in Regulatory Affairs
Brenda Bagby independently manages multiple projects within the regulatory affairs domain at AtriCure. Her project management skills enable her to oversee various regulatory initiatives effectively, ensuring that all submissions and documentation meet the necessary standards and timelines. This role requires a high level of organization and attention to detail, which she consistently demonstrates.